AuthorisedTherapeutic exploratory (Phase II)Interventional

GeranylGeranylAcetone as prevention for postoperative Atrial Fibrillation (GENIALITY)

This trial, called GENIALITY, is investigating whether a medication called Teprenone (also known by its chemical name, GeranylGeranylAcetone) or a type of dietary oil (medium-chain triglycerides, or MCT oil, known as Miglyol 812N) can prevent an irregular heartbeat called atrial fibrillation after someone has surgery. Postoperative atrial fibrillation is a common complication where the heart beats too fast and unevenly after an operation. Researchers will use a portable heart monitor called a Holter monitor to check if patients develop this condition after their surgery. They will also look at how these substances affect certain stress-response proteins in the body to understand how they might work. This is an early-stage study to see if these treatments are promising.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Stichting Amsterdam UMC

Enrolment target

146

Start

30 Sep 2024

Postoperative Atrial Fibrillation

What is this study about?

Heart surgery can sometimes lead to a side effect called atrial fibrillation. This is when the upper chambers of your heart beat irregularly and very quickly, which can make you feel breathless, tired, or dizzy. While it often goes away on its own, it can sometimes lead to more serious problems.

This study, called GENIALITY, is trying to find out if certain treatments can help prevent this irregular heartbeat from happening after surgery. Researchers are looking at two different things: one is a medicine called Teprenone, which is currently used to treat stomach ulcers in some countries. The other is a type of natural oil called medium-chain triglycerides (MCT oil), similar to what you might find in coconut oil or some supplements.

The main goal of the study is to see if taking either Teprenone or the MCT oil can lower the chances of developing this irregular heartbeat after an operation. The researchers want to understand how these substances might work in the body, so they will also be looking at certain 'stress-response' proteins in blood and tissue samples. This is a Phase II study, which means it’s an early step to see if these treatments are safe and if they seem to work, before potentially moving on to larger studies.

Key takeaways

This study explores treatments to prevent an irregular heartbeat after surgery.
It's an early-stage study looking at a stomach ulcer drug (Teprenone) and a type of oil (MCT oil).
Heartbeats will be monitored with a portable device called a Holter monitor.
Participation involves taking a study treatment and undergoing heart monitoring and some tests.
Both men and women, aged 18 and over, are eligible to be considered.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults are welcome to participate if they meet other criteria. Both men and women can take part in this research.

The study is specifically for people who are having surgery. The researchers are looking for individuals who might be at risk of developing an irregular heartbeat (atrial fibrillation) after their operation. Your medical team will help determine if this study is right for you based on your health and planned surgery.

It's important to discuss with your doctor if you are interested in this study. They will review your full medical history to confirm if you are suitable and if there are any reasons why you shouldn't participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Am I preparing to have surgery?
Am I willing to potentially take a study drug or oil and be monitored?
Am I able to attend follow-up appointments?
Do I understand that I might receive a dummy treatment (placebo)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study medication (Teprenone), the MCT oil, or a dummy treatment (placebo) before and after your surgery. You wouldn't know which one you are receiving. After your operation, you would wear a small portable device called a Holter monitor for a certain period. This device continuously records your heart's electrical activity and helps researchers detect any irregular heartbeats.

Throughout the study, you would have regular check-ups, which might include blood tests and possibly collection of small tissue samples (like from fat around the heart) during your surgery, if appropriate and with your consent. These visits and tests help the research team understand how well the treatment is working and if there are any side effects. The total duration of your involvement in the study would be explained in detail by the research team, covering the period before, during, and after your surgery, including follow-up appointments.

Potential risks and benefits

Taking part in this study might offer a potential benefit if one of the treatments helps prevent an irregular heartbeat after your surgery, but this is not guaranteed as it's an investigational study. There is also a small risk of side effects from the study medication or MCT oil, or discomfort from procedures like blood tests or wearing the heart monitor. Your health and safety are paramount, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is atrial fibrillation?

Atrial fibrillation is when the upper chambers of your heart beat irregularly and very quickly. It's often called an 'irregular heartbeat' and can make you feel tired or dizzy.

What is a 'Holter monitor'?

A Holter monitor is a small, portable device you wear that records your heart's electrical activity continuously, usually for 24-48 hours. It helps doctors detect irregular heartbeats that don't always happen.

What is Teprenone?

Teprenone is a medication that's used in some countries to treat stomach ulcers. In this study, we're exploring if it could also help prevent irregular heartbeats after surgery.

What are 'medium-chain triglycerides' (MCT oil)?

MCT oil is a type of fat found in foods like coconut oil. It's often used as a dietary supplement. We're studying if this oil can help prevent an irregular heartbeat after surgery.

Will I know if I'm getting the drug, the oil, or nothing?

No, you won't know directly. This is called 'blinding' and helps ensure the study results are fair and unbiased. You might receive the study drug, the MCT oil, or a dummy treatment (placebo).